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Method of producing enteric soft capsule

A technology of enteric-coated soft capsules and enteric-coated capsules, applied in the field of preparation of enteric-coated soft capsules, can solve problems such as poor adhesion and poor formability, and achieve the effect of preventing bad smell and aftertaste and excellent preparation performance

Active Publication Date: 2017-02-22
FUJI CAPSULE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, two or more polysaccharides are necessary, and alkali metal salts are necessary during kneading, so the gelation caused by the two polysaccharides is promoted when the capsule is formed, resulting in very poor formability (very poor adhesion) )The problem

Method used

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  • Method of producing enteric soft capsule
  • Method of producing enteric soft capsule

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preparation example Construction

[0024] The preparation method of the enteric-coated soft capsule of the present invention is not particularly limited, and is a preparation method of an enteric-coated soft capsule comprising the following steps: (a) configuring a low-methoxy fruit containing gelatin and a degree of amidation of 5-25% Enteric-coated capsule shell liquid of glue, and (b) using the enteric-coated capsule shell liquid prepared in step (a) to encapsulate the capsule content by die-cutting method. Enteric property refers to the property of dissolving in the intestine without being dissolved in the stomach.

[0025] The gelatin in the present invention is not particularly limited, and includes gelatin with a freezing strength of 160-300 Bloom, preferably 200-300 Bloom. In addition, two or more gelatins with different freezing strengths can be mixed and used. For example, two kinds of gelatins with freezing strengths of 200 Bloom and 300 Bloom can be mixed to adjust the freezing strength.

[0026] A...

Embodiment 1

[0036] [Disintegration experiment]

[0037] (Preparation of Soft Capsules)

[0038] Disperse 24 mass parts of pectin (DE30, DA17) in 30 mass parts of glycerin, dissolve in warm water (80°C), and further add 60 mass parts of gelatin (300Bloom) and 16 mass parts of gelatin (200Bloom) at 70 °C, filtered through a 100-mesh sieve (0.15 mm in sieve opening), and defoaming under reduced pressure to prepare the capsule shell liquid of the present invention. Furthermore, 30 parts by mass of glycerin was dissolved in warm water at 80°C, and 100 parts by mass of gelatin (200 Bloom) was further added to dissolve at 70°C, filtered through a 100-mesh sieve (mesh opening: 0.15mm) and defoamed under reduced pressure , to prepare the control coating solution. Each capsule shell liquid has fluidity at 60°C, and a rotating device can be used for all of them.

[0039] Then, adopt the rotary mode soft capsule preparation device (manufactured by Fuji Capsule Co., Ltd.), 250mg capsule content (fi...

Embodiment 2

[0043] Formulation and enteric properties test 1

[0044] (Preparation of Soft Capsules)

[0045] 31.5 parts by mass of pectin shown in the following Table 1 were dispersed in 40 parts by mass of glycerin, dissolved in warm water (80° C.), and 79 parts by mass of gelatin (300 Bloom) and 21 parts by mass of gelatin (200 Bloom) were further added. Dissolve at 70° C., filter through a 60-mesh sieve (0.25 mm in sieve opening), and defoam under reduced pressure to prepare the capsule shell liquid. In the table, DE represents the degree of esterification (%) of each pectin, and DA represents the degree of amidation (%) of each pectin.

[0046] Table 1

[0047] Pectin type DE DA pectin-1 31-38 12-18 pectin-2 26-34 16-19 pectin-3 30-35 6-12 pectin-4 22-27 20-23 Pectin-5 33-38 0

[0048] Then, using a flat-plate soft capsule preparation device (manufactured by Fuji Capsule Co., Ltd.), medium-chain fatty acid triglycerides (MCT: coc...

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Abstract

The present invention addresses the problem of providing a method of producing soft capsules that are enteric and exhibit superior production characteristics. In this method, enteric soft capsules are produced by means of steps (a) and (b), which are: (a) a step for preparing an enteric capsule coating solution which contains gelatin and a low methoxyl pectin having a degree of amidation of 5-25%; and (b) a step for using the prepared enteric capsule coating solution prepared in (a) to encapsulate capsule contents by means of a punching technique. It is preferable for the gelatin to have a jelly strength of 160-330 Bloom, for the degree of esterification of the low methoxyl pectin to be 20-40%, and for the enteric capsule coating solution to contain 30-35 parts by mass of the low methoxyl pectin per 100 parts by mass of the gelatin.

Description

technical field [0001] The present invention relates to a kind of preparation method of enteric-coated soft capsule, more specifically, relate to a kind of preparation method of enteric-coated soft capsule, it comprises the following steps: Enteric-coated capsule shell liquid of methoxy pectin, and (b) using the enteric-coated capsule shell liquid prepared in step (a) to encapsulate the capsule content by die-cutting method. Background technique [0002] Traditionally, capsules containing various active ingredients have been widely reported. As the shell material of these capsules, gelatin, agar, and the like are widely used. However, shells made of gelatin and agar, etc., cannot use acid-labile substances as active ingredients because they disintegrate in the stomach in an acidic environment. [0003] In recent years, enteric-coated capsules have been developed. Enteric-coated capsules are capsules whose outer shell is resistant to acids so that instead of disintegrating...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K47/10A61K47/36A61K47/42
CPCA61K47/10A61K47/36A61K47/42A61K31/202A61K9/4816A61K9/4825A61K9/5036A61K9/5089A61K9/4833
Inventor 渡边和彦长谷川洋明稻叶直规下川义之加藤健治
Owner FUJI CAPSULE
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